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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Commission v France (Approximation of laws) [2004] EUECJ C-155/03 (22 June 2004)
URL: http://www.bailii.org/eu/cases/EUECJ/2004/C15503.html
Cite as: [2004] EUECJ C-155/03, [2004] EUECJ C-155/3

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IMPORTANT LEGAL NOTICE - The source of this judgment is the web site of the Court of Justice of the European Communities. The information in this database has been provided free of charge and is subject to a Court of Justice of the European Communities disclaimer and a copyright notice. This electronic version is not authentic and is subject to amendment.

JUDGMENT OF THE COURT (Fifth Chamber)
22 June 2004 (1)

(Failure by a Member State to fulfil its obligations - Directive 2000/70/CE - Medical devices incorporating stable derivates of human blood or human plasma - Failure to transpose)

In Case C-155/03,

Commission of the European Communities, represented by B. Stromsky and R. Amorosi, acting as Agents, with an address for service in Luxembourg,

applicant,

v

French Republic, represented by G. de Bergues and C. Bergeot-Nunes, acting as Agents,

defendant,

APPLICATION for a declaration that, by failing to adopt the laws, regulations and administrative provisions necessary to comply with Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ 2000 L 313, p. 22), or in any event by failing to notify those provisions to the Commission, the French Republic has failed to fulfil its obligations under that directive,

THE COURT (Fifth Chamber),

composed of: C. Gulmann, President of the Chamber, A. La Pergola (Rapporteur) and S.von Bahr, Judges,

Advocate General: D. Ruiz-Jarabo Colomer,
Registrar: R. Grass,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

1. By application lodged at the Court Registry on 3 April 2003, the Commission of the European Communities brought an action under Article 226 EC for a declaration that, by failing to adopt the laws, regulations and administrative provisions necessary to comply with Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ 2000 L 313, p. 22), or in any event by failing to notify those provisions to the Commission, the French Republic has failed to fulfil its obligations under that directive.

Law
2. Article 2 of Directive 2000/70 provides:
‘1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 13 December 2001. They shall immediately inform the Commission thereof.
…
2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.
...’

Pre-litigation procedure
3. In accordance with the procedure provided for in the first paragraph of Article 226 EC, the Commission, after giving the French Republic the opportunity to submit its observations, sent a reasoned opinion to that Member State, by letter of 18 July 2002, calling on it to take the necessary measures to comply with that opinion within two months of its notification.
4. By letters of 23 September 2002 and 13 February 2003, the French authorities indicated that a draft decree was being prepared in order to transpose into domestic law both Directive 2000/70 and Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (OJ 2002 L 6, p. 50).

The action
5. The Commission states that the French Republic neither adopted nor published, within the prescribed periods, the provisions necessary in order to comply with Directive 2000/70 and, in any event, did not inform the Commission of such provisions, thereby failing to fulfil its obligations under Article 2 of the Directive.
6. The French Government states that, in order to transpose Directive 2000/70, a draft decree was being prepared, but that it had been delayed because of a problem relating to the transposition into national law of the concept of ‘substance which may be considered to be a medicinal product or a medicinal product derived from human blood’.
7. According to settled case-law whether a Member State has failed to fulfil its obligations must be determined by reference to the situation prevailing in the Member State at the end of the period laid down in the reasoned opinion (see, in particular, Case C-147/00 Commission v France [2001] ECR I-2387, paragraph 26, and Case C-173/01 Commission v Greece [2002] ECR I-6129, paragraph 7). It is also settled case-law that a Member State cannot rely on provisions, practices or circumstances in its internal legal order to justify failure to comply with obligations and time-limits laid down by a directive (see Case C-419/01 Commission v Spain [2003] ECR I-4947, paragraph 22, and Case C-433/02 Commission v Belgium [2003] ECR I-0000).
8. It is not disputed that the French Republic has not adopted the measures necessary to ensure the transposition of Directive 2000/70 within the period prescribed for that purpose.
9. Consequently, it must be held that, by failing to adopt all the laws, regulations and administrative measures necessary to comply with Directive 2000/70, the French Republic has failed to fulfil its obligations under Article 2 of that directive.

Costs
10. Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission sought an order for costs against the French Republic and the latter has been unsuccessful, the French Republic must be ordered to pay the costs.



On those grounds,

THE COURT (Fifth Chamber)

hereby:
1. Declares that, by failing to adopt the laws, regulations and administrative measures necessary to comply with Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma, the French Republic has failed to fulfil its obligations under Article 2 of that directive;
2. Orders the French Republic to pay the costs.

Gulmann	La Pergola	von Bahr

Delivered in open court in Luxembourg on 22 June 2004.

R. Grass

C. Gulmann

Registrar

President of the Fifth Chamber

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1 - Language of the case: French.